Tara M. Mastracci, Roy K. Greenberg, Matthew J. Eagleton
Vascular Surgery, The Cleveland Clinic Foundation, Cleveland, OH.
OBJECTIVES: Branched and fenestrated repair is an effective method for treatment of complex aortic aneurysms. However, the long-term durability of branches is not well reported.
METHODS: Prospective data collected for all patients enrolled in a physician sponsored investigational device exemption trial for branched and fenestrated endografts was analyzed. Imaging studies and electronic records were used to supplement the prospectively collected dataset when necessary. Incidence of branch stent reintervention, endoleak repair, stent fracture, migration, rupture and death were calculated. Time to event analysis was performed for a composite endpoint of reintervention for any branch. Univariable and multivariable analysis were performed to identify related variables. Device failure was reported as a function of exponential decay to capture the loss of freedom from complications over time.
RESULTS: Between the years 2001 and 2010, 650 patients underwent endovascular aortic repair with branched or fenestrated devices. Through 9 years of follow up (mean 3 years [SD 2.3]), secondary procedures were performed for 0.6% of celiac, 4% of SMA, 6% of right renal, and 5% of left renal artery stents. Mean time to reintervention was 237 days (SD 354 days). The 30 day, 1 year and 5 year freedom from any branch intervention was 98% (95% Confidence interval [CI] 96-99%), 94% (95% CI 92-96%), 84% (95% CI 78-90%) respectively (Figure 1). Death resulted from branch stent complications in only 2 patients, related to SMA thrombosis. Multivariable analysis revealed no factors as independent predictors of branch reintervention.
CONCLUSIONS: Branches, following branched or fenestrated aortic repair, appear to be durable, and are rarely the cause of patient death. The absence of long-term data on the branch patency in open repair precludes comparison, yet the lower morbidity and mortality risk coupled with longer-term durability data will further alter the balance of repair options.
AUTHOR DISCLOSURES: M. J. Eagleton, Cook Medical, Consulting fees or other remuneration (payment), Bolton Medical, Consulting fees or other remuneration (payment); R. K. Greenberg, Cook Medical Inc., Consulting fees or other remuneration (payment); T. M. Mastracci, Cook Medical, Inc., Consulting fees or other remuneration (payment).
Posted April 2012